DOSAGE AND ADMINISTRATION
For treatment of active ulcerative colitis in adult patients, the usual dose is three 750 mg COLAZAL capsules to be taken 3 times a day (6.75 g per day) for up to 8 weeks. Some patients in the adult clinical trials required treatment for up to 12 weeks.
For treatment of active ulcerative colitis in pediatric patients, aged 5 to 17 years, the usual dose is EITHER:
- three 750 mg COLAZAL capsules 3 times a day (6.75 g per day) for up to 8 weeks;
- one 750 mg COLAZAL capsule 3 times a day (2.25 g per day) for up to 8 weeks.
Use of COLAZAL in the pediatric population for more than 8 weeks has not been evaluated in clinical trials. [See Clinical Studies Section]
COLAZAL capsules may also be administered by carefully opening the capsule and sprinkling the capsule contents on applesauce. The entire drug/applesauce mixture should be swallowed immediately; the contents may be chewed, if necessary, since contents of COLAZAL are NOT coated beads/granules. Patients should be instructed not to store any drug/applesauce mixture for future use.
If the capsules are opened for sprinkling, color variation of the powder inside the capsules ranges from orange to yellow and is expected due to color variation of the active pharmaceutical ingredient.
Teeth and/or tongue staining may occur in some patients who use COLAZAL in sprinkle form with food.
DOSAGE FORMS AND STRENGTHS
COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black.